Inventory sparing catheter systems and methods

ABSTRACT

Some embodiments relate to a catheter system having a changeable or adjustable working length. The catheter system can comprise a proximal end, a distal end, and a first axial lumen configured to receive a guidewire formed through at least a portion of the catheter body. A first opening can be formed through a portion of the catheter body and be in communication with the first lumen. The sheath can be rotatable, axially movable, or otherwise changeable from at least a first position to a second position, wherein the sheath can substantially cover the first opening in the catheter body in the first position, and can substantially expose the first opening in the catheter body in the second position.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a divisional of, and claims priority from, U.S.patent application Ser. No. 12/578,473 (titled “INVENTORY SPARINGCATHETER SYSTEM”), filed on Oct. 13, 2009, which claims the benefit ofU.S. Provisional Patent Application No. 61/104,678 (titled “CATHETERSYSTEM”), filed Oct. 10, 2008, the entireties of both of which arehereby incorporated by reference as if fully set forth herein.

BACKGROUND OF THE DISCLOSURE

1. Field of the Invention

The present disclosure relates to percutaneous catheters, moreparticularly, to percutaneous catheters having a changeable workinglength.

2. Description of the Related Art

One of the differences with the use of peripheral percutaneoustransluminal angioplasty (PTA) catheters compared to percutaneoustransluminal coronary angioplasty catheters (PTCA) is the ubiquitousneed for different working lengths for PTA catheters. Coronary cathetersare designed to traverse a fixed distance between the access point(common femoral, brachial or radial artery) and the heart (or sometimesthe brain) to treat lesions. Thus, a single standard PTCA catheterlength of 135 cm satisfies almost all the distances needed to treatthese lesions irrespective of the patient height and habitus, while atthe same time not having too much redundant catheter outside the body.In difference, the target lesions for PTA vary in location and distancefrom the access site so a single catheter length, if too short, will notreach all the lesions and, if too long, will leave a long unwieldysegment outside the body that is difficult to keep in the sterile field.

For example, PTA catheters may be used to treat lesions very close tothe access site with an ispsilateral iliac approach where the distancefrom the sheath in the common femoral artery to the lesion may be only 5to 20 cm. Compare this to the patients with lesions in the great vesselslike the subclavian artery where the target treatment sites arefrequently over 100 cm remote from the femoral access site.

A problem arises when using too long of a catheter in the shortdistances because the length requires guide wires two times the catheterlength, and these often extend below the patient's feet while on theinterventional table, and the devices become clumsier and can take twopeople to load and unload the catheter on the wire. This also creates anincreased risk for catheter contamination as the proximal end of thecatheter can flip up and hit an unsterile monitor or even reach thefloor. In these instances the entire system must be discarded and theprocedure begins all over again. Hence, there is a preference forshorter catheters when the target lesion is close to the access site,and for longer catheters when treating more distal lesions that cannotbe reached by shorter catheters. Shorter catheters are simpler in theclose proximity cases and require less labor and time under fluoroscopy(i.e. radiation exposure).

This need for different length catheters creates a burden on the enduser in the hospital catheter lab to stock large amounts of inventorydue to all the combinations of lengths and sizes. Catheters may bechosen by guide wire size (e.g., 0.014″, 0.018″, or 0.035″), balloonpressures/compliance (i.e. high pressure non-compliant, or low pressurecompliant), over a range of balloon diameters and balloon lengths, andby whether the systems are balloon only or balloons with stents mountedon them. In the domain of PTA, the inventory is doubled by the need for2 or more working lengths. This leads to thousands of units beingstocked and accounted for in the hospital catheter lab, for example upto 3 wire sizes×2 pressure types×10 diameters×8 balloon lengths×2catheter lengths, plus having multiples of each size available. Layeredon top of this, the catheterization laboratory may need multiple producttypes from multiple suppliers since different products are needed fordifferent lesions.

Recent changes in Joint Commission on the Accreditation of HealthcareOrganizations (JCAHO) guidelines make it more difficult for hospitals tomaintain inventory and protect products from contamination. Manyhospitals have shifted to closed inventory management systems withlimited space. In a typical hospital, about 60 percent of the totalsupply cost is driven by three clinical service areas: surgery,cardiology and pharmacy (source: 2004 VHA Supply Cost BenchmarkingDatabase; VHA, Inc.). Forty percent of supply costs can be attributed toimplants, stents, and other devices (source: Serb, Chris; StrategicSavings; Hospitalconnect.com; Apr. 16, 2004). Add to this that manyhospitals are pushing companies to provide products on consignment, thenadditional costs are also funneled back to the companies thatmanufacture the product.

SUMMARY OF SOME EXEMPLIFYING EMBODIMENTS

Some embodiments of this disclosure relate to a catheter system having acatheter body comprising a proximal end, a distal end, and a first lumenformed through at least a portion of the catheter body. The first lumencan be configured to receive a guidewire. In some embodiments, a firstopening can be formed through at least a portion of the catheter body.The first opening can be in communication with the first lumen. In someembodiments, the catheter system can have a sheath (also referred toherein as an outer sheath) supported by the catheter body, the sheathhaving a second opening formed through an outer wall of the sheath. Thesheath can be configured to be movable between at least a first positionand a second position. In some embodiments, in the second position, atleast a portion of the second opening of the sheath is approximatelyaligned with the first opening of the catheter body, and, in the firstposition, no portion of the second opening of the sheath is aligned withthe first opening of the catheter body.

Some embodiments of this disclosure relate to a catheter systemcomprising a catheter body having a proximal end, a distal end, and afirst lumen formed through at least a portion of the catheter body, thefirst lumen being configured to receive a guidewire. A first opening canbe formed through at least a portion of the catheter body, the firstopening being in communication with the first lumen. Additionally, asheath can be supported by the catheter body. The sheath can have asecond opening formed through an outer wall of the sheath. In someembodiments, the sheath can be movable between at least a first positionand a second position. The catheter system can be configured such thatat least a portion of the second opening of the sheath is adjacent tothe first opening of the catheter body when the sheath is in the firstposition and such that no portion of the second opening of the sheath isadjacent to the first opening of the catheter body when the sheath is inthe second position.

Some embodiments of this disclosure relate to a catheter systemcomprising a catheter body having a proximal end, a distal end, and afirst lumen formed axially through at least a portion of the catheterbody, the first lumen being configured to receive a guidewire. Thecatheter system can have a first opening formed through at least aportion of the catheter body, the first opening being in communicationwith the first lumen. The catheter body can be biased to be angled at anacute angle adjacent to the first opening when the catheter body is in arelaxed configuration.

Some embodiments of this disclosure relate to a catheter systemcomprising a catheter body having a proximal end, a distal end, and afirst lumen formed through at least a portion of the catheter body. Thefirst lumen can be configured to receive a guidewire. A diverter can bepositioned at any of a plurality of positions along the length of thecatheter body. In some embodiments, the catheter body can besubstantially sealed along the length thereof such that the first lumenis substantially sealed along the length thereof. The diverter can beconfigured such that at least a portion of the diverter passes throughthe catheter body such that an opening formed in the divertercommunicates with the first lumen, whereby a guidewire that is advancedthrough the first lumen can be advanced through the opening formed inthe diverter.

Some embodiments of this disclosure relate to a catheter systemcomprising a catheter body having a proximal end, a distal end, and afirst lumen formed axially through at least a portion of the catheterbody, the first lumen being configured to receive a guidewire. A firstopening can be formed through at least a portion of the catheter body,the first opening being in communication with the first lumen. Thecatheter system can also have a sheath supported by the catheter body,the sheath being slidable relative to the catheter body. The sheath canbe movable between at least a first position and a second position. Inthe first position, the first opening can be substantially covered bythe sheath. In the second position, the first opening can besubstantially uncovered. Further, when the sheath is in the secondposition, the catheter system can be configured to direct a guidewirebeing advanced through the first lumen to pass through the firstopening. In some embodiments, the catheter body can define an inflectionpoint adjacent to the first opening, the inflection point being theapproximate point wherein the catheter body defines a bend, a curve, anangle, or other suitable change in the orientation of the catheter body.The catheter body can be movable between at least a first configurationand a second configuration, wherein an angle at the inflection point isgreater in the first configuration than in the second configuration.

Some embodiments of this disclosure relate to a catheter systemcomprising a catheter body having a proximal end, a distal end, and afirst lumen formed axially through at least a portion of the catheterbody, the first lumen being configured to receive a guidewire. A firstopening can be formed through at least a portion of the catheter body,the first opening being in communication with the first lumen. Thecatheter system can further comprise a sheath supported by the catheterbody, the sheath having a second opening formed through an outer wallthereof. In some embodiments, the sheath can be movable between at leasta first position and a second position such that, in the secondposition, at least a portion of the second opening of the sheath can beapproximately aligned with the first opening of the catheter body, and,in the first position, no portion of the second opening of the sheath isaligned with the first opening of the catheter body.

Some embodiments of this disclosure relate to a catheter systemcomprising a catheter body having a proximal end, a distal end, and afirst lumen formed axially through at least a portion of the catheterbody, the first lumen being configured to receive a guidewire, and afirst opening formed through at least a portion of the catheter body,the first opening being in communication with the first lumen. In someembodiments, the catheter body can define an inflection point adjacentto the first opening, the inflection point being the approximatelocation wherein the catheter body defines a bend having an angle.Further, the catheter body can be movable between at least a firstconfiguration and a second configuration, and the angle can be greaterin the first configuration than in the second configuration.

Some embodiments of this disclosure relate to a catheter systemcomprising a catheter body comprising a proximal end, a distal end, anda first lumen axially formed through at least a portion of the catheterbody, the first lumen being configured to receive a guidewire, and adiverter that can be positioned at any of a plurality of positions alongthe length of the catheter body. In some embodiments, the diverter canbe configured such that at least a portion of the diverter passesthrough the catheter body into the first lumen such that an openingformed in the diverter communicates with the first lumen, whereby aguidewire that can be advanced through the first lumen can be advancedthrough the opening formed in the diverter.

Some embodiments of this disclosure relate to a method of using acatheter, comprising advancing a catheter body over a guidewirepositioned within a bodily vessel so that the guidewire passes at leastpartially through a first lumen formed axially through at least aportion of the catheter body and through a first opening of the catheterbody, moving a sheath positioned about the catheter body from a firstposition to a second position, and diverting the guidewire so that, whenthe sheath is in the second position, the guidewire passes through thefirst opening formed in the catheter body as the catheter is advancedover the guidewire. In some embodiments, the sheath can substantiallycover the first opening when the sheath is in a first position. In someembodiments, at least a portion of the first opening can be uncoveredwhen the sheath is in the second position.

Some embodiments of this disclosure relate to a method of using acatheter, comprising advancing a distal portion of a catheter body overa guidewire positioned within a bodily vessel so that the guidewirepasses through a lumen formed axially in the catheter body, divertingthe guidewire through a side-wall opening formed in the catheter body,and advancing the distal portion of the catheter into an introducersheath positioned in a patient's body to a treatment site whilemaintaining a proximal portion of the catheter body at least up theside-wall opening proximal of the introducer sheath. The side-wallopening can be in communication with the lumen.

Some embodiments of this disclosure relate to a method of using acatheter, comprising advancing a catheter body into a patient'svasculature, the catheter body comprising a proximal end, a distal end,a first lumen configured to receive a guidewire formed axially throughat least a portion of the catheter body, and a bend at an inflectionpoint adjacent to the first opening. The catheter body can be movablebetween at least a first configuration and a second configuration, andthe angle of the bend can be greater in the first configuration than inthe second configuration. The method can further comprise moving thecatheter body from the first configuration to the second configurationto reduce the angle of the bend, and advancing the catheter body over aguidewire positioned within a bodily vessel so that the guidewire passesthrough the first lumen and past the first opening of the catheter body.

Some embodiments of this disclosure relate to a method of using acatheter, comprising advancing the catheter over a guidewire positionedwithin a bodily vessel so that the guidewire passes through a firstlumen formed in a catheter body. The method can also comprise moving asheath positioned about the catheter body from a first position (whereinthe sheath can substantially cover a first opening formed in thecatheter body) to a second position (wherein at least a portion of thefirst opening is not covered by the sheath). The first opening formed inthe catheter body can be in communication with the first lumen formed inthe catheter body. The method can also comprise diverting the guidewireso that, when the sheath is in the second position, the guidewireadvances through the first opening formed in the catheter body as thecatheter is advanced over the guidewire.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing summary, as well as the following detailed description ofthe preferred embodiments of the present invention, will be betterunderstood when read in conjunction with the appended drawings, inwhich:

FIG. 1A is a perspective view of an embodiment of a catheter system.

FIG. 1B is a side view of the embodiment of the catheter systemillustrated in FIG. 1A.

FIG. 1C is a section view of the embodiment of the catheter system shownin FIG. 1A, taken through line 1C-1C in FIG. 1B.

FIG. 2 is a side view of another embodiment of a catheter system,showing the catheter system in a longer inserted length configuration.

FIG. 3 is a side view of the embodiment of a catheter system shown inFIG. 2, showing the catheter system in a shorter inserted lengthconfiguration.

FIG. 4 is a side view of another embodiment of a catheter system,showing the catheter system in a shorter inserted length configuration.

FIG. 5 is a side view of the embodiment of the catheter system shown inFIG. 4, showing the catheter system in a longer inserted lengthconfiguration.

FIG. 6 is a perspective view of another embodiment of a catheter system.

FIG. 7 is a perspective view of the embodiment of the slider mechanismshown in FIG. 6.

FIG. 8 is a side view of the embodiment of the slider mechanism shown inFIG. 6.

FIG. 9 is an end view of the embodiment of the slider mechanism shown inFIG. 6.

FIG. 10 is a side view of another embodiment of a catheter system.

FIG. 11 is a top view of an embodiment of the mandrel shown in FIG. 10.

FIG. 12 is a side view of an embodiment of the mandrel shown in FIG. 10.

FIG. 13A is an enlarged section view of a portion of the embodiment ofthe catheter system shown in FIG. 10, defined by curve 13A-13A shown inFIG. 10.

FIG. 13B is an enlarged section view of a portion of the embodiment ofthe catheter system shown in FIG. 10, defined by line 13B-13B shown inFIG. 13A.

FIG. 13C is an enlarged section view of a portion of another embodimentof a catheter system, defined by line 13C-13C shown in FIG. 13A.

FIG. 14A is a side view of another embodiment of a catheter system,showing the catheter system in an extended configuration.

FIG. 14B is a side view of the embodiment of the catheter system shownin FIG. 14A, showing the catheter system in a shorter inserted lengthconfiguration.

FIG. 15A is a section view of the embodiment of the catheter systemshown in FIG. 14A, taken through line 15A-15A in FIG. 14B.

FIG. 15B is a section view of the embodiment of the catheter systemshown in FIG. 14A, taken through line 15B-15B in FIG. 14B.

FIG. 16A is a side view of another embodiment of a catheter system,showing the catheter system in a first configuration.

FIG. 16B is a side view of the embodiment of a catheter system shown inFIG. 16A, showing the catheter system in a second configuration.

FIG. 16C is an enlarged section view of the embodiment of the cathetersystem shown in FIG. 16A, taken through line 16C-16C in FIG. 16A.

FIG. 16D is an enlarged section view of the embodiment of the cathetersystem shown in FIG. 16A, taken through line 16D-16D in FIG. 16B.

FIG. 17A is a side view of another embodiment of a catheter system,showing the catheter system in a first configuration.

FIG. 17B is a side view of the embodiment of a catheter system shown inFIG. 17A, showing the catheter system in a second configuration.

FIG. 17C is an enlarged section view of the embodiment of the cathetersystem shown in FIG. 17A, taken through line 17C-17C in FIG. 17B.

FIG. 18A is a side view of another embodiment of a catheter system,showing the catheter system in an extended configuration.

FIG. 18B is a side view of the embodiment of the catheter system shownin FIG. 18A, showing the catheter system in a shorter inserted lengthconfiguration.

FIG. 18C is a side view of an embodiment of a mandrel that can be usedwith the embodiment of the catheter system shown in FIGS. 18A and 18B.

FIG. 19 is a perspective view of another embodiment of a cathetersystem.

FIG. 20 is a perspective view of the embodiment of a catheter systemshown in FIG. 19, with a portion of the housing removed for clarity.

FIG. 21 is an exploded view of the embodiment of a catheter system shownin FIG. 19.

FIG. 22 is a perspective view of another embodiment of a cathetersystem.

FIG. 23 is a perspective view of the embodiment of a catheter systemshown in FIG. 22, with a portion of the housing removed for clarity.

FIG. 24 is a top view of the embodiment of a catheter system shown inFIG. 22

DETAILED DESCRIPTION OF SOME EXEMPLIFYING EMBODIMENTS

The embodiments of the present disclosure reduce catheter inventory byproviding balloon catheter or any other suitable catheter having anadjustable length. Having the capability to adjust the working length ofthe catheter can reduce the number of inventoried catheterssignificantly, in some cases in half. Some embodiments can utilize anotch or opening in the catheter shaft or body at a position where itwould be advantageous to permit a guidewire to exit. In someembodiments, the notch location can be the same as in a shorter catheterlength, in most cases approximately 80-85 cm proximal of the tip of thecatheter. The opening can also be located close enough to the proximalend of the catheter such that it does not enter the introducer sheath(or the body). For example, the catheter can be configured such that theopening will be covered if it is to be inserted into the guide catheteror introducer sheath, i.e., if an extended working length is needed forlesion access.

Additionally, with conventional apparatuses, the inflation lumen can beapproximately 1-2 feet behind where the physician is standing (near thesheath), causing him/her to have to move back and forth to operate theinflation lumen. To solve this dilemma, as will be described in greaterdetail, in some embodiments, the catheter can have a movable inflationport that can be movable to accommodate the physician's position.

In some embodiments, a catheter can be provided that can have a catheterbody having a guidewire lumen and an inflation lumen axially formedtherein. An inflatable balloon can be supported on a distal portion ofthe catheter body. The catheter can be configured such that the workinglength (e.g., the length of the catheter to be positioned inside apatient during use) of the catheter body can be increased or decreaseddepending on the individual patient need.

FIG. 1A is a perspective view of an embodiment of a catheter system 20.FIG. 1B is a side view of the embodiment of the catheter system 20illustrated in FIG. 1A. FIG. 1C is a section view of the embodiment ofthe catheter system 20 shown in FIG. 1A, taken through line 1C-1C inFIG. 1B. In some embodiments, the catheter system 20 can comprisefeatures, components, configurations, or other details found inconventional catheter systems, in addition or in the alternative tofeatures, components, configurations, or other details described herein.

With reference to FIGS. 1A-1C, the catheter system 20 can comprise acatheter body 22 having an inflation lumen 24 and a guidewire lumen 26.At least a portion of, or the entire length of, the guide wire lumen 26can be configured to slidingly receive a guidewire 28 (omitted from FIG.1A for clarity). The guidewire 28 can exit the lumen 26 at the distalend of the catheter body 22 through an opening (not illustrated) incommunication with the guidewire lumen 26.

An interface mechanism 32 can be positioned on the catheter body 22 tosurround at least a portion of the outside surface of the catheter body22. In some embodiments, the interface mechanism 32 can be configured tobe slidingly positionable along the length of the catheter body 22. Theinterface mechanism 32 can also be configured to be completely removablefrom the catheter body 22. For example, the interface mechanism 32and/or the catheter body 22 can have detents, clamps, or other featuresto selectively secure the interface mechanism 32 at a desired positionalong the length of the catheter body 22.

The guidewire lumen 26 can be configured to be at least substantiallysealed along a substantial portion of its length other than at theopening accessed by the interface mechanism 32. In some embodiments, theinterface mechanism 32 comprises a lever arm or blade 34 that isconfigured to create an opening or provide access to a preexistingopening in the lumen wall between the guidewire lumen 26 and an outsidesurface 22 a of the catheter body 22. The lever arm or blade 34 canprovide a passageway 36 to the guidewire lumen 26 at any of a variety oflongitudinal positions on the catheter body 22.

In some embodiments, the lever or blade 34 creates an opening bypressing down on the lumen wall to open a slit 36, as illustrated inFIG. 1C. The blade 34 can also be used to open a portion of a slitcreated in the lumen wall between the outside surface 22 a of thecatheter body 22 and the guidewire lumen 26. FIG. 1C depicts a cathetercross-section that comprises a preformed opening or slit 38 allowingaccess to the guidewire lumen 26 at a multitude of locations along thelength of the catheter body 22. In some embodiments, as depicted inFIGS. 1A and 1B, the lever arm or blade 34 is configured to extend intoan opening or slit 38 in the lumen wall and to divert the guidewire 28out of the lumen 26. In some embodiments, the lever or blade 34 extendsinto the opening or slit 38 to divert the guidewire 28 out of the lumen26.

In some embodiments, the catheter system 20 can be configured to permitthe location of the passageway 36 to be moved as the interface mechanism32 is moved along the catheter body 22, while sealing the other portionsof the catheter body 22 so that the guidewire lumen remainssubstantially sealed along its length. In some embodiments, the openingor slit 38 can be formed in the catheter body 22 adjacent to theguidewire lumen 26. The opening or slit 38 can be configured so that theblade 34 can create the opening along any desired portion of thecatheter body, even with the guidewire 28 occupying the opening 36. Theopening or slit 38 can be self-sealing such that it is biased to form aclosed seal along the length of the catheter body 22 adjacent to thelumen 26.

The sealed passageway 36 can be configured to receive the guidewire 28and provide a sealed conduit for the guidewire 28 to the guidewire lumen26. In this arrangement, the interface mechanism 32 can be moved alongthe length of the catheter body 22 to provide the adjustment of theposition of the opening 36. In this arrangement, the working length ofthe catheter system 20 can be changed by moving the interface mechanism32 along the length of the catheter body 22.

In some embodiments, the interface mechanism 32 can define a hingemember 40 and a latching mechanism 42. The hinge member 40 and latchingmechanism 42 shown most clearly in FIG. 1A can be configured such that auser can open a cover portion 44 of the interface mechanism 32 so thatthe interface mechanism 32 can be removed from or assembled with thecatheter body 22.

FIG. 2 is a side view of another embodiment of a catheter system 50,showing the catheter system 50 in a longer inserted lengthconfiguration. FIG. 3 is a side view of the embodiment of a cathetersystem 50 shown in FIG. 2, showing the catheter system 50 in a shorterinserted length configuration. In some embodiments, the catheter system50 can have a catheter body 52, a sliding mount 54, an inflation lumenfitting 56, and a guidewire exchange port 58. An inflation balloon 62can be supported by the catheter body 52. As illustrated, the slidingmount 54 can be slidably positionable on the catheter body 52 so thatthe position of the inflation lumen fitting 56 (which can have a luerfitting on the end thereof) can be adjustable. For example, in thelonger inserted length configuration shown in FIG. 2, the inflationlumen fitting 56 can be positioned farther away from the guidewireexchange port 58 as compared to the shorter inserted lengthconfiguration of the catheter system 50 shown in FIG. 3. In someembodiments, a user can shorten the distance between the inflation lumenfitting 56 by sliding the inflation lumen fitting 56 along the catheterbody 52 toward a guidewire exchange port 58 through which a guidewire 60can pass to enter into or exit from the guidewire lumen formed in thecatheter body 52. In some embodiments, the guidewire exchange port 58can be in a fixed position along the catheter body 52. In someembodiments, the position of the guidewire exchange port 58 can beadjustable.

In some embodiments, the sliding mount 54 can be moved toward the distalend 52 a of the catheter body 52 (e.g., closer to the guidewire exchangeport 58) to shorten the working portion of the catheter body 52. Theshorter inserted length configuration is illustrated in FIG. 3. In thisconfiguration, the user then can work with a shorter catheter andguidewire working length, with the inflation port 56 being close to theguidewire port 58. This innovation enables the physician not to have tomove down the operating table to actuate an inflation device coupledwith the inflation lumen of the catheter system 50.

In some embodiments, the sliding mount 54 can be pulled back toward theproximal end 52 b of the catheter body 52 to lengthen the working lengthor portion of the catheter body 52. This configuration is illustrated inFIG. 2.

In some embodiments, all or a portion of the catheter body 52 can bestiffened with a stiffening mandrel, braids, wires, coils, a stiff orrigid material, or otherwise to enable the catheter body 52 to be pushedwithout buckling or inadvertently bending during use of the cathetersystem 50. In some embodiments, the distance between the location of theguidewire port 58 and a coupling 64 (discussed further below) can bebetween approximately 40 cm and approximately 80 cm. In someembodiments, the distance between the location of the guidewire port 58and the distal end of the catheter 52 a can be approximately 60 cm orgreater.

In the illustrated embodiment, the guidewire 60 can pass through theguidewire lumen and exit the catheter body 52 at the distal end 52 athereof. Additionally, in some embodiments, an inflation balloon 62 canbe supported by the catheter body 52 near the distal end 52 a of thecatheter body 52. As such, the catheter system 50 can be configured foran angioplasty treatment, for stent delivery or other treatment forwhich a balloon is useful.

In some embodiments, the catheter system 50 can have an inflation lumencoupling 64 that can provide a coupling between the inflation lumenfitting or port 56 and the remaining portion of the catheter body 52. Alength of tubing 66 can provide a flexible conduit between the inflationport 56 and the coupling 64.

FIG. 4 is a side view of another embodiment of a catheter system 80,showing the catheter system 80 in a shorter inserted lengthconfiguration. FIG. 5 is a side view of the embodiment of the cathetersystem 80 shown in FIG. 4, showing the catheter system 80 in a longerinserted length configuration. As illustrated in FIGS. 4 and 5, thecatheter system 80 can have a catheter body 82, an inflation balloon 84,and a quick connect coupling 86. The catheter body 82 can include aninflation lumen and a guidewire lumen. As illustrated in FIG. 4, thequick connect coupling 86 can be used to connect a short extension 88 tothe catheter body 82. The short extension 88 can have an inflation lumenport 92 and an exit port 94 for the guidewire lumen. A long extension 90shown in FIG. 5 can have an inflation lumen port 92 and an exit port 94for the guidewire lumen. The catheter system 80 can be configured suchthat the short extension 88 and the long extension 90 can beinterchangeably joined to the quick connect coupling 86.

By attaching the long extension 90 to the catheter body 82 with thequick connect coupling 86, a user can extend the working length of thecatheter body 82 so that the length of the catheter body 82 isincreased. In some embodiments, the length of the catheter body 82 canbe approximately 100 cm or more. In some embodiments, the long extension90 can be approximately 55 cm or greater in length, or between 50 cm orless and approximately 75 cm or more. In some embodiments, the catheterbody 82 can be approximately 80 cm in length from the distal end of thecatheter body 82 to the quick connect coupling 86.

In some embodiments, the quick connect coupling 86 can be configured tobe insertable into a vessel within a body. In some embodiments, thequick connect coupling 86 can be configured to be pliable and also haveindexing features so that the inflation lumen and guidewire lumen in theextension portion 88, 90 can be aligned with the inflation lumen andguidewire lumen in the catheter body 82 when the quick connect couplingis joined. The quick connect coupling can be sufficiently short to notcreate a long, stiffened section in the catheter body 82. The quickconnect coupling 86 can be formed from one or more pliable materials. Insome embodiments, the quick connect coupling 86 can be a snap fitconnector or similar connector that can have indexing features tomaintain the alignment of the lumens in the catheter body 82. In someembodiments, the quick connect coupling 86 can be a twist or threadedconnector having indexing features to ensure the alignment of theguidewire and inflation lumens in the catheter body 82.

FIG. 6 is a perspective view of another embodiment of a catheter system100 having a catheter body 102, an inflation balloon 104, and a slidermechanism 106 (also referred to herein as a diverter). FIGS. 7-9 are aperspective view, a side view, and an end view, respectively, of theembodiment of the slider mechanism 106 shown in FIG. 6. The slidermechanism 106 can be configured to divert the guidewire 114 outside of aguidewire lumen 110. A typical over-the-wire inflation luer of the kindcommonly found in the art can be attached to the proximal end 102 a ofthe catheter body 102.

With reference to FIG. 6, a lengthwise slit 108 can be formed in thecatheter body 102 between the outer surface of the catheter body 102 andthe guidewire lumen 110, but not into the inflation lumen 112. The slit108 can extend along the entire length of the catheter body 102, oralong only a portion of the length of the catheter body 102. In someembodiments, the catheter body 102 can be configured such that the slit108 is substantially self-sealing. Some embodiments of the slidermechanism 106 can have a first portion 106 a sized and configured to begripped by a user's hands or fingers, and a second portion 106 bconfigured to be supported within a lumen of the catheter body 102. Forexample, in some embodiments, the slider mechanism 106 can be supportedby the catheter system 100 such that the first portion 106 a of theslider mechanism 106 can be located external to the catheter body 102and guidewire lumen 110 while second portion 106 b of the slidermechanism 106 can be slidably received within the guidewire lumen 110.

In some embodiments, the second portion 106 b of the slider mechanism106 can have a cross-sectional shape that is similar to thecross-sectional shape of the guidewire lumen 110. In some embodiments,the second portion 106 b can have a tubular shape or have one or morecurved surfaces. In some embodiments, the second portion 106 b can havea flat bottom surface, such as the bottom surface 106 c shown in FIG.106 b, to abut against a similarly shaped surface in the guidewire lumen110. The flat bottom surface 106 c can be configured to stabilize theslider mechanism 106 with respect to the catheter body 102 to inhibitmovement of or rotation of the slider mechanism 106 relative to thecatheter body 102 about a longitudinal axis of the catheter body 102. Insome embodiments, the second portion 106 b of the slider mechanism 106can have a tubular or C-shaped cross-sectional shape. The first portion106 a of the slider mechanism 106 can be sized and shaped so that a usercan easily grasp and manipulate the slider mechanism 106.

With reference to FIGS. 6-9, a guidewire 114 can be assembled with thecatheter system 100 by advancing the guidewire 114 through the distalend 102 b of the catheter body 102 and feeding the guidewire 114 throughthe guidewire lumen 110. Once the guidewire 114 reaches the slidermechanism 106, as mentioned, the slider mechanism 106 can divert theguidewire 114 outside of the guidewire lumen 110. The slider 106 can bedistally or proximally advanced or translated until the desired positionof the slider mechanism 106 is reached. After the guidewire 114 has beenadvanced through the catheter body 102 and the slider mechanism 106, atypical over-the-wire inflation luer fitting can be coupled with theproximal end 102 a of the catheter body 102. In this arrangement, theguidewire 114 can remain within the guidewire lumen 110 of the portionof the catheter body 102 that can be inserted into the patient, and theworking length of the catheter body 102 can be adjusted by sliding theslider 106 toward or away from the distal end of the catheter.

FIG. 10 is a side view of another embodiment of a catheter system 150.FIG. 11 is a top view of an embodiment of the mandrel 162 shown in FIG.10. FIG. 12 is a side view of an embodiment of the mandrel 162 shown inFIG. 10. FIG. 13A is an enlarged section view of a portion of theembodiment of the catheter system 150 shown in FIG. 10, defined by curve13A-13A shown in FIG. 10. FIG. 13B is an enlarged section view of aportion of the embodiment of the catheter system 150 shown in FIG. 10,defined by line 13B-13B shown in FIG. 13A.

With reference to FIGS. 10-13B, the catheter system 150 can comprise acatheter body 152 having an inflation balloon 154, an inflation port 156in communication with an inflation lumen 157, and a guidewire lumen 159for receiving a guidewire 158. In some embodiments, the catheter body152 can have some or all of the same features of any typical over thewire type catheter wherein the guidewire 158 can be advanced through theentire length of the catheter body 152 and exit through the proximal end152 a of the catheter body 152 when the mandrel 162 is not positioned inthe guidewire lumen 159.

In the illustrated arrangement, the guidewire 158 can be advancedthrough a portion of the catheter body 152 so that the guidewire 158exits through an opening 160 (also referred to herein as a port ornotch) formed in the catheter body 152. In some embodiments, more thanone opening 160 can be formed in the catheter body 152 or any othercatheter body disclosed herein at any of a range of positions along thecatheter body so that the guidewire 158 can exit the catheter body 152at any of a wide range of locations. The mandrel 162 can be insertedinto the catheter body 152 through the proximal end 152 a of thecatheter body and can be configured to help guide or deflect theguidewire 158 through the opening 160 if so desired. In someembodiments, the mandrel 162 can have a curved distal end 162 a todivert the guidewire 158 through the opening 160 when oriented properly.In some embodiments, with reference to the mandrel 162 shown in FIG.13A, the distal end portion 162 a of the mandrel 162 can be beveled orslanted to divert the guidewire 158 from the guidewire lumen 159.

In some embodiments, the mandrel 162 and/or catheter body 152 can beindexed or keyed such as at the proximal end or along any portion of thelength of the catheter body 152 to ensure the desired orientation of themandrel 162 within the guidewire lumen 159 so that the guidewire 158 canexit smoothly. For example, with reference to FIG. 13B, the mandrel 162and/or the guidewire lumen 159 through which the mandrel 162 is advancedcan be keyed, indexed, or otherwise configured such that the beveled orangled end portion 162 a of the mandrel 162 is biased to be in anoptimal rotational orientation with respect to the opening 160. The endportion 162 a can be angled by bending the end portion 162 a of themandrel 162. In some embodiments, an optimal rotational orientation withrespect to the opening 160 can be one in which the end portion 162 a ofthe mandrel 162 smoothly diverts the guidewire out of the opening 160when the mandrel 162 has been advanced into the desired axial positionwithin the guidewire lumen.

As illustrated in FIG. 13B, the guidewire lumen 159 can define a recessor channel 161 therein which can receive the end portion 162 a thereinor otherwise be configured to prevent the inadvertent rotation of themandrel 162. In this configuration, the rotational or radial orientationof the mandrel 162 can be controlled. The channel 161 can be formedalong all of or a portion of the length of the guidewire lumen 159.

Additionally, with reference to FIG. 13C, the guidewire lumen 159 candefine a recess or channel 161 therein which can receive a ridge orprotrusion 163 of the mandrel 162 therein or otherwise be configured toprevent the inadvertent rotation of the mandrel 162. The embodiment ofthe mandrel 162 illustrated in FIG. 13C can have a beveled or angled endportion (not illustrated) configured to divert a guidewire 158 throughthe opening 160 in the catheter body 152. In this configuration, therotational or radial orientation of the mandrel 162 can be controlled.The channel 161 illustrated in FIG. 13C can be formed along all of or aportion of the length of the guidewire lumen 159.

In some embodiments, a handle 164 can be supported at the proximal end162 b of any embodiments of the mandrel 162 or other mandrels disclosedherein to assist the user in manipulation or removal of the mandrel. Thehandle 164 supported at the proximal end 162 b of the mandrel 162 canalso be keyed such that, when the handle is coupled with a feature onthe proximal end 152 a of the catheter 152, the mandrel's slanted orcurved distal end 162 a can be oriented to divert the guidewire 158through the opening 160.

In some embodiments, the opening 160 can be positioned approximately 80cm from the distal end 152 b of the catheter body 152. In someembodiments, the opening 160 can be positioned at any desired orsuitable location along the length of the catheter body 152. Asmentioned above, when the mandrel 162 is removed from the guidewirelumen, the guidewire 158 can continue through the entire length of thecatheter body 152 so that the entire length of the catheter body 152 cancomprise a working length. In some embodiments, a cover or plug (notillustrated) can be positioned over the opening 160 to substantiallycover the opening 160 when substantially the entire length of thecatheter body 152 is desired to be inserted into the patient.

In some embodiments, the catheter body 152 can be strengthened orsupported in the region of or adjacent to the opening 160 to prevent thecatheter body 152 from buckling or kinking at or adjacent to the opening160 due to the interruption of the outer surface of the catheter or thedecrease in the cross-sectional area at the opening 160. In someembodiments, a solid mandrel or support can be inserted in the adjacentballoon inflation lumen or another lumen formed in the catheter body 152to strengthen the catheter body 152 in the region of the opening 160.The mandrel or support can extend past the location of the opening 160,and can be removably or non-removably secured at the proximal end of thecatheter using adhesive, welds, fasteners, or by any other suitablemeans. The mandrel can be tapered at the distal end or modified toreduce its stiffness to prevent the end of the wire from accidentlyperforating the lumen and exiting the catheter shaft.

In some embodiments (not illustrated), a removable clip can also bepositioned on the outside of the catheter body 152 around or adjacent tothe opening 160 to help the user locate the opening 160 and also assistin diverting the guidewire 158 out of the opening 160 when a shortercatheter length is desired. An interface mechanism, such as the slidinginterface mechanism 32 described above, can also be attached to thecatheter body 152 to permit the location of the inlet to the inflationlumen to be brought closer to the opening 160.

FIGS. 14A and 14B are side views of another embodiment of a cathetersystem 170, showing an embodiment of a slideable assembly 172incorporating an outer cover or sheath 174 that can be used to cover anopening 176 (also referred to herein as a port or notch) formed in thecatheter body 178 when the longer length of the catheter is being used.Some embodiments of the catheter system 170 can have one or anycombination of the same features, components, configurations, or detailsof any other catheter system embodiments disclosed herein. FIG. 14Ashows the catheter system 170 in a longer inserted length configurationwherein the slideable assembly 172 has been axially advanced away fromthe proximal end 178 a of the catheter body 178 such that the cathetersystem 170 is in an extended position. FIG. 14B shows the cathetersystem 170 in a shorter inserted length configuration wherein theslideable assembly 172 has been axially retracted to be positionedcloser to the proximal end 178 a of the catheter body 178 such that thecatheter system 170 is in a shorter inserted length configuration. Withreference to FIGS. 14A and 14B, the working length (i.e., the lengththat is designed to be insertable into the introducer sheath, orpatient) of the catheter system 170 in the first or longer insertedlength configuration (represented by D1 in FIG. 14A) is significantlygreater than the working length of the catheter system 170 in the secondor shorter inserted length configuration (represented by D2 in FIG.14B).

In some embodiments of the catheter system 170 or any of the cathetersystem embodiments disclosed herein, the working length of the cathetersystem 170 in the first or longer inserted length configuration(represented by D1 in FIG. 14A) can be from 125 cm or less toapproximately 150 cm or more, or from approximately 130 cm toapproximately 140 cm, or from approximately 133 cm to approximately 137cm, or to or from any values within these ranges. In some embodiments ofthe catheter system 170 or any of the catheter system embodimentsdisclosed herein, the working length of the catheter system 170 in thesecond or shorter inserted length configuration (represented by D2 inFIG. 14B) can be from 65 cm or less to approximately 100 cm or more, orfrom approximately 70 cm to approximately 90 cm, or from approximately75 cm to approximately 85 cm, or to or from any values within theseranges.

In the extended position as shown in FIG. 14A, the sheath 174 of theslideable assembly 172 has been extended in the direction represented byarrow A1 in FIG. 14A so that the sheath 174 substantially covers theopening 176. In this position, the sheath 174 or any sheath of any otherembodiment of the catheter system disclosed herein can provideadditional structural support to the catheter body 178 at or adjacent tothe position of the opening 176. Additionally, in some embodiments, thesheath 174 or any sheath of any other embodiment of the catheter systemdisclosed herein can be configured to provide a relatively fluid tightseal around the outside surface of the catheter body (such as, withoutlimitation, catheter body 178). In some embodiments, with the sheath 174or any other sheath herein positioned so as to cover the opening in thecatheter body, the guidewire lumen can be used to inject fluids into thepatient's vasculature.

In the shorter inserted length configuration, as illustrated in FIG.14B, the sheath 174 of the slideable assembly 172 can be retracted inthe direction represented by arrow A2 in FIG. 14B so that the sheath 174does not cover the opening 176. In this position, a guidewire can passthrough the opening 176. In some embodiments, the catheter system 170can be configured such that a mandrel or other suitable device orfeature can selectively divert a guidewire through the opening oropening 176.

In some embodiments, the slideable assembly 172 can be incorporated intoany of the other catheters or catheter systems described herein or knownin the field, including but not limited to the catheter system 150 orany other catheter system described herein. Further, in someembodiments, the catheter system 170 can have any of the components,features, or other details of any of the catheter systems disclosedherein or any other catheter systems known in the field.

In this arrangement, when the slideable assembly 172 has been advancedto cover the opening 176, as shown in FIG. 14A, the opening 176 can besubstantially covered to prevent guidewires and other devices advancedthrough the proximal or distal end of the catheter lumen frominadvertently exiting the opening 176. When a shorter version of thecatheter body 178 is preferred (or a shorter working length), theslideable assembly 172 can be retracted proximally (i.e., in thedirection represented by arrow A2 in FIG. 14B) and an optional diverterrod (such as without limitation the mandrel 162 shown in FIG. 10 anddescribed above) can be positioned in the guidewire lumen to divert theguidewire out of the opening 176. Then the catheter can be loaded ontothe guide wire and advanced until the guide wire exits the opening 176.At this point, the guidewire and catheter 170 can be manipulatedseparately. As mentioned, when the longer version of the catheter system170 is needed (e.g., a longer working length), the slideable assembly172 can be extended distally to cover the opening 176 and the diverterrod can be removed. Then the catheter can be loaded onto the guide wireand advanced until the guide wire passes through the proximal end 178 aof the catheter body 178.

In some embodiments, the opening 176 or any other port or notch hereincan be positioned relative to the distal end of the catheter body 178 toensure that a sufficient length of the catheter body 178 is provideddistal of the opening 176. Positioning the opening 176 as described canensure that the opening 176 remains outside of, i.e., proximal of, theintroducer sheath when a guidewire is advanced through the opening 176.These features minimize the chance for tissue within the vasculaturegetting trapped between a guidewire and the body of the catheter 170 orthe opening 176, which could lead to injury to the patient.

FIGS. 15A and 15B are section views of two embodiments of the cathetersystem shown in FIGS. 14A and 14B, taken through line 15A-15A in FIG.14B. In some embodiments, as with any of the other embodiments of thecatheters disclosed herein, the catheter body 178 can have a lumen 180configured to removably or non-removably receive a stiffening mandrel orsupport 182 therein. The lumen 180 can be disposed parallel to theguidewire lumen 184. The stiffening mandrel 182 can be sized andconfigured to increase the strength and/or stiffness of the catheterbody 178 adjacent to the opening 176. Alternatively, with reference toFIG. 15B, the catheter system 170 can be configured such that thestiffening mandrel or support 182 can be received within all or aportion of the inflation lumen 186 that can be formed in the catheterbody 178. In any of the embodiments disclosed herein, the stiffeningmandrel 182 can have a solid cross-section, a hollow cross-section, orany combination thereof.

FIGS. 16A and 16B show another embodiment of a catheter system 200 thathas a first or longer inserted length configuration and a second orshorter inserted length configuration, respectively. Some embodiments ofthe catheter system 200 can have one or any combination of the samefeatures, components, configurations, or details of any other cathetersystem embodiments disclosed herein. The catheter system 200 can have aslideable assembly 202 incorporating an outer cover or sheath 204 thatcan be used to cover a notch or opening 206 formed in the catheter body208 when the longer length of the catheter is being used. In someembodiments, the sheath 204 or, more particularly, the catheter body 208can comprise more than one opening that can be independently exposed toprovide the medical practitioner with a range of different workinglengths of the catheter system 200. The catheter system 200 or any othercatheter system herein can be configured such that the space between thesheath 204 and the catheter body 208 is substantially sealed or tight toprevent or inhibit any blood flow or other leakage between the sheath204 and the catheter body 208.

FIG. 16A shows the catheter system 200 in a longer inserted lengthconfiguration wherein the slideable assembly 202 has been axiallyretracted toward the proximal end 208 a of the catheter body 208 suchthat the catheter system 200 is in an extended position. FIG. 16B showsthe catheter system 200 in a shorter inserted length configurationwherein the slideable assembly 202 has been axially advanced away fromthe proximal end 208 a of the catheter body 208 such that the cathetersystem 200 is in a shorter inserted length configuration. In theretracted position as shown in FIG. 16A, the outer cover 206 of theslideable assembly 202 has been retracted in the direction representedby arrow A3 in FIG. 16A so that the notch or opening 210 (also referredto as a second opening) in the outer cover 206 is not aligned with thenotch or opening 206 formed in the catheter body 208. In this position,where the openings 206, 210 are not aligned and the opening 206 is notexposed, the outer cover 206 can provide structural support to thecatheter body 208 at or adjacent to the position of the opening 206.

In the axially advanced position, as illustrated in FIG. 16B, the sheath204 of the slideable assembly 202 can be advanced in the directionrepresented by arrow A4 in FIG. 16B so that the opening 210 is alignedwith and provides access through the sheath 204 to the opening 206. Inthis position, a guidewire can pass through the substantially alignedopenings 206, 210. Advantageously, a portion of the sheath 204 adjacentto the opening 210 can provide some additional structural support at theaxial position of the opening 206. In some embodiments, the cathetersystem 200 can be configured such that a mandrel or other suitabledevice or feature can selectively divert a guidewire through the opening206 and 210. In some embodiments, instead of being axially movable, thesheath 204 of the slideable assembly 202 can be rotatable to align theopenings 206, 210 or misalign the openings 206, 210.

In some embodiments, the slideable assembly 202 can be incorporated intoany of the other catheters or catheter systems described herein or knownin the field, including but not limited to the catheter system 150 or170. Further, in some embodiments, the catheter system 200 can have anyof the components, features, or other details of any of the cathetersystems disclosed herein or any other catheter systems known in thefield.

In this arrangement, when the slideable assembly 202 has been retractedto cover the opening 206, as shown in FIG. 16A, the opening 206 can besubstantially covered to prevent guidewires and other devices advancedthrough the proximal or distal end of the catheter lumen frominadvertently exiting the opening 206. When a shorter working lengthversion of the catheter body 208 is preferred, the slideable assembly202 can be advanced distally (i.e., in the direction represented byarrow A4 in FIG. 16B). In some techniques, a diverter rod (such aswithout limitation the mandrel 162 shown in FIG. 10 and described above)can be positioned in the guidewire lumen to divert the guidewire out ofthe opening 206. Then the catheter can be loaded onto the guide wire andadvanced proximally from a distal end port of the catheter body 208until the guide wire exits the opening 206. At this point, the guidewireand catheter system 200 can be manipulated separately. As mentioned,when the longer version of the catheter system 200 is needed, theslideable assembly 202 can be extended distally to cover the opening 206and the diverter rod can be removed. Then the catheter can be loadedonto the guide wire and advanced until the guide wire passes through theproximal end 208 a of the catheter body 208.

In any of the embodiments disclosed herein, one or more of thecomponents of the catheter system (for example, without limitation, thecatheter system 200) can be indexed or otherwise configured to maintainthe desired radial orientation, axial position, or otherwise of thecomponents of the catheter system. For example, in some embodimentswherein the sheath 204 can be configured to be axially movable withrespect to the catheter body 208, the sheath 204, catheter body 208,and/or other components of the catheter system 200 can have channels,depressions, protrusions, tabs, or other indexing or keying features toprevent the opening 210 formed in the sheath 204 from becoming radiallymisaligned with respect to the opening 206 formed in the catheter body208.

For example, an inside surface of the sheath 204 can define a channel212 longitudinally formed therein along at least a portion of the lengthof the sheath 204, and an outer surface of the catheter body 208 canhave a protrusion or tab 214 formed thereon configured to engage withthe channel 212 formed in the sheath 204. In an alternative embodiment(not illustrated), the tab (such as the tab 214) can be disposed on thesheath 204 and the channel (such as channel 212) can be disposed on thecatheter body 208. In these configurations, to align the respectiveopenings 206, 210, the medical practitioner need only be concerned withthe axial positioning of the openings 206, 210 and may align thesecomponents merely by changing the axial position of the sheath 204 withrespect to the catheter body 208.

In any of the embodiments disclosed herein, although not required, oneor more of the components of the catheter system (for example, withoutlimitation, the catheter system 200 described above) can havedepressions or detents or other biasing or indicating features formedtherein. The depressions, detents, or other biasing or indicatingfeatures can be configured to selectively bias the relative componentssuch as the sheath 204 and the catheter body 208 in one of two or moredesired positions relative to one another.

FIG. 16D is an enlarged section view of the embodiment of the cathetersystem 200 shown in FIG. 16A, taken through line 16D-16D in FIG. 16B.The section view defined by FIG. 16D is taken through the inflationlumen 216 of the catheter body 204. With reference to FIG. 16D, aninside surface of the sheath 204 can define one or more depressions ordetents 236 formed therein at various locations on the inside surface ofthe sheath 204, and an outer surface of the catheter body 208 can have arounded or otherwise shaped protrusion or tab 238 formed thereonconfigured to selectively engage with one of the depression ordepressions 236 formed in the sheath 204. In an alternative embodiment(not illustrated), the tab or protrusion 238 can be disposed on thesheath 204 and the depression or depressions 236 can be disposed on thecatheter body 208. The depressions and protrusions, or other similarfeatures can be located at a variety of predetermined radial orlongitudinal locations, depending on whether the sheath 204 is axiallymovable, radially movable, or movable in both the axial and radialdirections with respect to the catheter body 208.

In this arrangement, the depressions or other biasing or indicatingfeatures formed in the sheath 204 and/or catheter body 208 can providethe user (which may be a medical practitioner) with a physicalindication, e.g., a tactile feedback, of the relative positioning of thesheath 204 and the catheter body 208. The tactile feedback provided tothe user that can indicate the relative positioning of the outer sleeveand the catheter body can be achieved not only by indicating featuresformed in the outer sleeve or catheter body, but also by configuring aproximal handle of any embodiments of the catheter systems disclosedherein to incorporate a spring that forces a button into one of two ormore slots. For example, a first slot could be configured for a distalsleeve position (i.e., a long catheter configuration) and a second slotcould be configured for a proximal sleeve position (i.e., a shortcatheter configuration).

In some embodiments, one depression 236 can be formed in the sheath 204at one position associated with the first or longer inserted lengthconfiguration of the catheter system 200, while another depression 236can be formed in the sheath 204 at a second position associated with thesecond or shorter inserted length configuration of the catheter system200. A protrusion or tab 238 formed in the catheter body 208 can beconfigured to engage with each one of the two or more depressions 236that can be formed in the sheath 204 so that the medical practitionercan feel when the sheath 204 has been positioned in the desired axial orradial position relative to the catheter body 208. Additionally, thesefeatures can be configured to bias the sheath 204 to remain in theselected axial or radial position with respect to the catheter body 208.

In any of the embodiments disclosed herein, the opening 206 or any othernotch or port disclosed herein can be positioned relative to the distalend of the catheter body 208 to ensure that a sufficient length of thecatheter body 208 is provided distal of the opening 206. In someembodiments, positioning the opening 206 as described can ensure thatthe opening 206 does not enter the introducer sheath or the patient'svasculature when a guidewire is advanced through the opening or opening206, thus preventing potential injury to the patient from the guidewire.

FIG. 17A is a side view of another embodiment of a catheter system 220,showing the catheter system 220 in a first configuration. FIG. 17B is aside view of the embodiment of a catheter system 220 shown in FIG. 17A,showing the catheter system 220 in a second configuration. FIG. 17C isan enlarged section view of the embodiment of the catheter system 220shown in FIG. 17A, taken through line 17C-17C in FIG. 17B. The sectionview defined by FIG. 17C is taken through the inflation lumen 240 of thecatheter body 224. In some embodiments, the catheter system 220 can haveany of the features, components, or details of any of the other cathetersystems disclosed herein, such as catheter system 200, in addition to orthe alternative to, any of the features described below or illustratedin the figures.

In some embodiments, such as illustrated in FIGS. 17A-17C, the sheath224 can be configured to be radially or rotationally movable withrespect to the catheter body 228 to align the openings 226, 230. Forexample, the rotatable assembly 222 can be rotated to rotate the sheath224 and, hence, the opening 230 formed in the sheath 224. Additionally,the sheath 224, catheter body 228, and/or other components of thecatheter system 220 can have channels, depressions, protrusions, tabs,or other indexing or keying features to prevent the opening 230 formedin the sheath 224 from becoming axially misaligned with respect to theopening 226 formed in the catheter body 228. For example, with referenceto FIG. 17C, an inside surface of the sheath 224 can define a channel232 partially or fully circumferentially formed therein, and an outersurface of the catheter body 228 can have a protrusion or tab 234 formedthereon configured to engage with the channel 232 formed in the sheath224.

Similar to the catheter system 200, in some embodiments, the cathetersystem 210 can have depressions or detents or other biasing orindicating features formed therein. The depressions, detents, or otherbiasing or indicating features can be configured to selectively bias therelative components such as the sheath 224 and the catheter body 228 inone of two or more desired positions relative to one another. In someembodiments, the channel 232 can have protrusions, tabs, stops, or othersimilar features to limit the degree of rotation of the sheath 224relative to the catheter body 228, or to assist with aligning theopenings 226, 230.

In an alternative embodiment (not illustrated), the tab 234 can bedisposed on the sheath 224 and the channel 232 can be disposed on thecatheter body 228. In this configuration, to align the respectiveopenings 226, 230, the medical practitioner need only be concerned withthe radial or rotational positioning of the openings 226, 230 and canalign the openings 226, 230 by changing the radial position of thesheath 224 with respect to the catheter body 228. The radial position ofthe sheath 224 with respect to the catheter body 228 and, hence, theradial position of the opening 230 with respect to the opening 226, canbe adjusted by rotating the sheath 224 about a longitudinal axis of thecatheter body 208.

FIGS. 18A and 18B are side views of another embodiment of a cathetersystem 260, showing an embodiment of a slideable assembly 262incorporating an outer cover or sheath 264 that can be used to cover anopening 266 (also referred to herein as a port or notch) formed in thecatheter body 268 when the longer length of the catheter is being used.Some embodiments of the catheter system 260 can have one or anycombination of the same features, components, configurations, or detailsof any other catheter system embodiments disclosed herein. FIG. 18Ashows the catheter system 260 in a longer inserted length configurationwherein the slideable assembly 262 has been axially advanced away fromthe proximal end 268 a of the catheter body 268 such that the cathetersystem 260 is in an extended position. FIG. 18B shows the cathetersystem 260 in a shorter inserted length configuration wherein theslideable assembly 262 has been axially retracted to be positionedcloser to the proximal end 268 a of the catheter body 268 such that thecatheter system 260 is in a shorter inserted length configuration. Someembodiments of the catheter system 300 can have one or any combinationof the same features, components, configurations, or details of anyother catheter system embodiments disclosed herein.

In the extended position as shown in FIG. 18A, the sheath 264 of theslideable assembly 262 has been extended in the direction represented byarrow A5 in FIG. 18A so that the sheath 264 substantially covers theopening 266. In this position, the sheath 264 or any sheath of any otherembodiment of the catheter system disclosed herein can provideadditional structural support to the catheter body 268 at or adjacent tothe position of the opening 266. Additionally, in some embodiments, thesheath 264 or any sheath of any other embodiment of the catheter systemdisclosed herein can be configured to provide a relatively fluid tightseal around the outside surface of the catheter body (such as, withoutlimitation, catheter body 268). In some embodiments, with the sheath 264positioned so as to cover the opening 266 in the catheter body, theguidewire lumen can be used to inject fluids into the patient'svasculature.

In the shorter inserted length configuration, as illustrated in FIG.18B, the sheath 264 of the slideable assembly 262 can be retracted inthe direction represented by arrow A6 in FIG. 18B so that the sheath 264does not cover the opening 266. In this position, a guidewire can passthrough the opening 266. As will be described, the catheter system 300can be configured such that, when the catheter system 270 is in theshorter inserted length configuration such as shown in FIG. 18B, amandrel or other diverting device is not required to divert a guidewirethrough the opening or opening 266. Rather, the angulation of thecatheter body 268 adjacent to the opening 266 can bias a guidewiretoward the opening 266 without the use of a mandrel or diverter.

In this arrangement, when the slideable assembly 262 has been advancedto cover the opening 266, as shown in FIG. 18A, the opening 266 can besubstantially covered to prevent guidewires and other devices advancedthrough the proximal or distal end of the catheter lumen frominadvertently exiting the opening 266. When a shorter version or workinglength of the catheter body 268 is preferred, the slideable assembly 262can be retracted proximally (i.e., in the direction represented by arrowA6 in FIG. 18B). The catheter system 260 can be configured such that, inthe shorter inserted length configuration as illustrated in FIG. 18B,the catheter body 268 is configured to bend or curve upwardly (forexample, without limitation, such that the catheter bends in a directionthat is away from the opening 266) in the portion of the catheter body268 adjacent to the opening 266. In some embodiments, the catheter body268 can bend or curve about an inflection point. The inflection pointcan be adjacent to a center point or an end point of the opening 266.

In some embodiments, the catheter body 268 can be substantially linear(in a relaxed state) along the lengths of the catheter body 268 proximalto and distal of the opening 266. In this configuration, as the cathetersystem 260 is being advanced over a guidewire 270, due to the curvatureof the catheter body 268 adjacent to the opening 266, the guidewire canbe directed out of the opening 266 without the use of a mandrel ordiverter positioned within the proximal portion of the guidewire lumen.

The catheter body 268 can be configured to be biased to curve upwardlyadjacent to the opening 266 in any of a number of different ways. Insome embodiments, a preformed, shaped mandrel, such as, withoutlimitation, the shaped mandrel 272 shown in FIG. 18C, can be embedded orotherwise positioned within the catheter body 268 so as to bias thecatheter body 268 to curve upwardly adjacent to the opening 266. Asillustrated in FIG. 18C, the shaped mandrel 272 can have a curve orangle 274 configured to coincide with the location of the opening 266formed in the catheter body 268 when the mandrel 270 has been positionedwithin the catheter body 268.

In some embodiments, the catheter body 268 can be configured such that,when the catheter is in the shorter inserted length configuration, asshown in FIG. 18B, the angle of curvature of the catheter body 268 at oradjacent to the opening 266 (represented by angle X as shown in FIG.18B) can be approximately 30 degrees relative to the proximal portion ofthe catheter body 268. In some embodiments, the angle of curvature ofthe catheter body 268 at or adjacent to the opening 266 can be fromapproximately 5 degrees or less to approximately 30 degrees or more, orfrom approximately 30 degrees to approximately 50 degrees relative tothe proximal portion of the catheter body 268. Additionally, in someembodiments, the desired angle of curvature of the catheter body 268 ator adjacent to the opening 266 can be selected based on the size of theopening 266 formed in the catheter body 268, the size of the guidewireto be advanced through the opening 266, and/or the smallest bend radiusthat can be substantially straightened by advancing the sheath 264thereover. Therefore, in some embodiments, the angle of the catheterbody 268 in the first position can be greater than the angle of thecatheter body 268 in the second position. The angle of the catheter body268 in the first position can be substantially greater than the angle ofthe catheter body 268 in the second position.

In some embodiments, the opening 266 can be configured such so that theangle required to divert a guidewire out of the guidewire lumen can beminimized. For example, without limitation, a proximal portion of theopening 266 can be angled or beveled so that a guidewire exiting theopening 266 when the catheter body 268 is in an angled (i.e., firstconfiguration), the guidewire will not be obstructed from exiting theopening 266 by the sidewall of the catheter body 268.

As discussed in greater detail below, in some embodiments, a removablemandrel (not illustrated) can move the catheter body 268 between thefirst and second configurations. The mandrel can have a predeterminedangle at an inflection point that can correspond with the inflectionpoint of the catheter body.

Accordingly, in some embodiments, the shaped mandrel can be positionedwithin an inflation lumen of the catheter body 268, imbedded within thewall of the catheter body, or positioned within a separate lumenconfigured to receive the shaped mandrel. The shaped mandrel can beformed from Nitinol heat set in the angled shape, or from stainlesssteel or any other suitable material. In some embodiments, the catheterbody 268 can be formed or heat set to have the desired angle adjacent tothe opening 266 so that an angled or shaped mandrel is not required.

The catheter body 268 can be configured such that, when the longerinserted length configuration of the catheter body 268 is desired, suchas is illustrated in FIG. 18A, the slideable assembly 262 can beextended distally in the direction A5 so that the sheath 264 covers theopening 266. In some embodiments, though not required, the sheath 264can be configured to overcome the angled or curved bias of the catheterbody 268 to substantially straighten the catheter body 268 as the sheath264 is being advanced over the opening 266 in the catheter body 268.Additionally, in some embodiments, a mandrel can be advanced through alumen in the catheter body, such as the inflation lumen, tosubstantially straighten the catheter body 268 adjacent to the opening266, when the longer inserted length configuration is desired. However,in some embodiments, the catheter system 260 can be configured such thatthe catheter body 268 remains at least partially curved or angledadjacent to the opening 266 in the longer inserted length configuration.Then the catheter can be loaded onto the guide wire and advanced untilthe guide wire passes through the proximal end 268 a of the catheterbody 268. In some embodiments, a user can move the catheter body 268with his or her hands to change the catheter body 268 from an angledconfiguration to an approximately straight configuration. The catheterbody 268 can be configured to be biased to remain in either the angledor the straight configuration.

In some embodiments, the opening 266 or any other port or notch hereincan be positioned relative to the distal end of the catheter body 268 toensure that a sufficient length of the catheter body 268 is provideddistal of the opening 266. Positioning the opening 266 as described canensure that the opening 266 remains outside of (i.e., proximal of) theintroducer sheath when a guidewire is advanced through the opening 266,and throughout a procedure in some cases. These features minimize thechance for tissue within the vasculature getting trapped between aguidewire and the body of the catheter 260 or the opening 266, whichcould lead to injury to the patient.

FIG. 19 is a perspective view of another embodiment of a catheter system300. Some embodiments of the catheter system 300 can have one or anycombination of the same features, components, configurations, or detailsof any other catheter system embodiments disclosed herein. Asillustrated FIG. 19, the catheter system can have a catheter body 302having an inflation port 304 in communication with an inflation lumen,and a guidewire lumen for receiving a guidewire. In some embodiments,the catheter body 302 can be curved or angled, such as with theembodiment of the catheter body 268 described above, or in someembodiments, the catheter body 302 can be can be straight, as describedabove. A slider mechanism 306 having a housing 308 and a releasemechanism 310 can be supported by the catheter body 302. The housing 308can have a first cover 308 a and a second cover 308 b that can be heldtogether about the catheter body 302 using adhesive, snap fit features,press fit features, sonic welds, or other suitable components orfeatures.

FIG. 20 is a perspective view of the embodiment of a catheter system300, with the second cover 308 b removed for clarity. FIG. 21 is anexploded view of the catheter system 300. With reference to FIGS. 19-21,the slider mechanism 306 can have a tip member 314 that can project fromthe distal end portion of the housing 308. The tip member 314 canprovide additional support to the catheter body 302 to substantiallyprevent the catheter body 302 from kinking or collapsing at a positionthat is distal of the housing 308. The tip member 314 can be strainrelief device of any suitable configuration. Additionally, the slidermechanism 306 or the tip member 314 can support an outer sheath 316,which can project distally from the end of the tip member 314. Withreference to FIG. 20, in some embodiments, the tip member 314 can beradially and axially supported within the housing 308 such that the tipmember 314 and the outer sheath are substantially prevented fromtranslating in an axial direction relative to the housing 308. In someembodiments, the housing 308 and/or tip member 314 can have annularprotrusions, annular channels, tabs, depressions, or other features tosubstantially prevent the tip member 314 and the outer sheath fromtranslating in the axial direction relative to the housing 308. In thisarrangement, the tip member 314 and the outer sheath 316 can move withthe housing 308 and other components of the slider mechanism 306 whenthe slider mechanism 306 is moved between at least a first and a secondposition.

The outer sheath 316 can be configured to extend over an outside surfaceof the portion of the catheter body 302 that extends distally beyond thehousing 308. Similar to other embodiments of catheter systems disclosedherein, the outer sheath 316 can be configured to translate axiallybetween at least a first and a second position so as to selectivelyexpose or cover an opening (not illustrated) in the catheter body 302through which a guidewire (not illustrated) can be advanced. Forexample, when slider mechanism is translated to the first position suchthat the catheter system 300 is in a first or longer inserted lengthconfiguration, the sheath 316 can cover the opening in the catheter body302. In this configuration, a guidewire can be advanced proximally pastthe opening in the catheter body 302 and continue through the guidewirelumen to the proximal end of the catheter body 302. Alternatively, whenslider mechanism is translated to the second position such that thecatheter system 300 is in a second or shorter inserted lengthconfiguration, the sheath 316 can expose the opening in the catheterbody 302 so that a guidewire can be advanced through the opening in thecatheter body so as to exit the catheter body 302 through the opening.

As will be described, the slider mechanism 306 can be moved from a firstposition, as illustrated in FIG. 20 wherein the slider mechanism 306 isin a forward position relative to the catheter body 302, to a secondposition (not illustrated) wherein the slider mechanism 306 is in arearward position relative to the catheter body 302. In someembodiments, the slider mechanism 306 can be configured to engage withat least two channels 320, 322 formed in the catheter body 302. Theslider mechanism 306 is in the first or forward position when engagedwith channel 320 (as illustrated in FIG. 20), and is in the second orrearward position when engaged with channel 322. With reference to FIG.21, the release mechanism 310 that is supported within the housing 308can be configured to selectively engage with the channels 320, 322. Aspring member 324, which can be a cantilevered spring member, can bias atab or other protrusion (not illustrated) supported by the releasemechanism 310 in the direction defined by arrow A7 shown in FIG. 20 toselectively engage with the channels 320, 322.

A portion of the release mechanism 310 can project through an opening330 in the housing 308 so that a user can depress the release mechanism310 against the bias of the spring member 324, so that the housing 308and the sheath 316 can be translated axially between at least the firstand second positions. In this arrangement, a user can depress therelease mechanism 310 in the direction defined by arrow A8 in FIG. 20 toallow the housing 308 to slide or translate axially relative to thecatheter body 302. Channels, protrusions, or other features, such as thechannels 334 formed on the inside of the housing 306 can be configuredto engage with or receive the catheter body 302 to provide increasedsupport to the housing 308 as the housing 308 is translated relative tothe catheter body 302. Additionally, in some embodiments, a stop or tab336 can be formed on the catheter body 302 to prevent theover-translation of the housing 308 relative to the catheter body 302.

In some embodiments, openings 338 can be formed in the housing 308 toallow a user to view the position of the housing 308 relative to thecatheter body 302, or to view other aspects of the catheter body 302.Further, in some embodiments, the catheter system 300 can support amandrel 340 having a handle portion 342. The mandrel 340 can beadvanceable within a lumen formed in the catheter body 302, such as aninflation lumen or separate lumen configured to receive the mandrel 340.The mandrel 340 can have any of the same features or shapes of any ofthe other mandrels disclosed herein.

FIG. 22 is a perspective view of another embodiment of a catheter system400. Some embodiments of the catheter system 400 can have one or anycombination of the same features, components, configurations, or detailsof any other catheter system embodiments disclosed herein. Asillustrated FIG. 22, the catheter system can have a catheter body 402having an inflation port 404 in communication with an inflation lumen,and a guidewire lumen for receiving a guidewire. In some embodiments,the catheter body 402 can be curved or angled, such as with theembodiment of the catheter body 268 described above, or in someembodiments, the catheter body 402 can be can be straight, as describedabove. A slider mechanism 406 can be supported within a housing 408. Theslider mechanism can have a release mechanism 410 configured toselective secure the slider mechanism 406 in the axial direction in oneof two or more predetermined positions. The housing 408 can have a firstcover 408 a and a second cover 408 b that can be held together about thecatheter body 402 using adhesive, snap fit features, press fit features,sonic welds, or other suitable components or features.

FIGS. 23 and 24 are a perspective view and a top view, respectively, ofthe embodiment of a catheter system 400, with the second cover 408 bremoved for clarity. With reference to FIGS. 22-23, the slider mechanism406 can have a tip member or strain relief device (not illustrated) thatcan be similar to the tip member 314 described above that can projectfrom the distal end portion of the housing 408. The tip member canprovide additional support to the catheter body 402 to substantiallyprevent the catheter body 402 from kinking or collapsing at a positionthat is distal of the housing 408. Additionally, the slider mechanism406 can support an outer sheath 416, which can project distally from theend of the tip member. In some embodiments, the tip member can beradially and axially supported within the housing 408 such that the tipmember and the outer sheath are substantially prevented from translatingin an axial direction relative to the housing 408. In some embodiments,the housing 408 and/or tip member can have annular protrusions, annularchannels, tabs, depressions, or other features to substantially preventthe tip member and the outer sheath from translating in the axialdirection relative to the housing 408. In this arrangement, the tipmember and the outer sheath 416 can move with the housing 408 and othercomponents of the slider mechanism 406 when the slider mechanism 406 ismoved between at least a first and a second position.

The outer sheath 416 can be configured to extend over an outside surfaceof the portion of the catheter body 402 that extends distally beyond thehousing 408. Similar to other embodiments of catheter systems disclosedherein, the outer sheath 416 can be configured to translate axiallybetween at least a first and a second position so as to selectivelyexpose or cover an opening (not illustrated) in the catheter body 402through which a guidewire (not illustrated) can be advanced. Forexample, when slider mechanism is translated to the first position suchthat the catheter system 400 is in a first or longer inserted lengthconfiguration, the sheath 416 can cover the opening in the catheter body402. In this configuration, a guidewire can be advanced proximally pastthe opening in the catheter body 402 and continue through the guidewirelumen to the proximal end of the catheter body 402. Alternatively, whenslider mechanism is translated to the second position such that thecatheter system 400 is in a second or shorter inserted lengthconfiguration, the sheath 416 can expose the opening in the catheterbody 402 so that a guidewire can be advanced through the opening in thecatheter body so as to exit the catheter body 402 through the opening.

As will be described, the slider mechanism 406 can be moved from a firstposition, as illustrated in FIG. 23 wherein the slider mechanism 406 isin a forward position relative to the catheter body 402, to a secondposition (not illustrated) wherein the slider mechanism 406 is in arearward position relative to the catheter body 402. In someembodiments, the slider mechanism 406 can be configured to engage withat least two channels 420, 422 formed in the housing 408. The slidermechanism 406 is in the first or forward position when engaged withchannel 420 (as illustrated in FIG. 23), and is in the second orrearward position when engaged with channel 422. With reference to FIG.21, the release mechanism 410 can have one or more opposing tabs 411that can selectively engage with the channels 420, 422. The channels420, 422 can be formed in radially opposing positions in the housing408. A spring member 424, which can be a cantilevered spring member, canbias each of the opposing tabs 411 supported by the release mechanism410 in the direction defined by arrows A9 shown in FIG. 20 toselectively engage with the channels 420, 422.

As illustrated, the tabs 411 can engage with the channels 420, 422 andextend through the housing 408 so that a user can depress the releasemechanism 410 against the bias of the spring member 424 by squeezing thetabs 411 together in the direction defined by arrows A10 shown in FIG.23, so that the slider mechanism 406 and the sheath 416 can betranslated axially between at least the first and second positions.Channels, protrusions, or other features, such as the protrusions 434formed on the inside of the housing 406 can be configured to engage withor receive the slider mechanism 406 to provide increased support to theslider mechanism 406 as the slider mechanism 406 is translated relativeto the catheter body 402.

In some embodiments, openings (not illustrated) can be formed in thehousing 408 to allow a user to view the position of the housing 408relative to the catheter body 402, or to view other aspects of thecatheter body 402. Further, in some embodiments, the catheter system 400can support a mandrel 440 having a handle portion 442. The mandrel 440can be advanceable within a lumen formed in the catheter body 402, suchas an inflation lumen or separate lumen configured to receive themandrel 440. The mandrel 440 can have any of the same features or shapesof any of the other mandrels disclosed herein.

Although the inventions have been disclosed in the context of a certainpreferred embodiments and examples, it will be understood by thoseskilled in the art that the present inventions extend beyond thespecifically disclosed embodiments to other alternative embodimentsand/or uses of the inventions and obvious modifications and equivalentsthereof. In addition, while a number of variations of the inventionshave been shown and described in detail, other modifications, which arewithin the scope of the inventions, will be readily apparent to those ofskill in the art based upon this disclosure. It can be also contemplatedthat various combinations or subcombinations of the specific featuresand aspects of the embodiments may be made and still fall within thescope of the inventions. Accordingly, it should be understood thatvarious features and aspects of the disclosed embodiments can becombined with or substituted for one another in order to form varyingmodes of the disclosed inventions. Thus, it can be intended that thescope of the present inventions herein disclosed should not be limitedby the particular disclosed embodiments described above.

1. A catheter system comprising: a catheter body comprising a proximalend, a distal end, and a first axial lumen extending continuouslythrough the catheter body from the distal to the proximal end of thecatheter body, the first lumen being configured to receive a guidewireand being configured to be selectively closeable; a first opening formedthrough at least a portion of the catheter body, the first opening beingin communication with the first lumen; and a sheath supported by thecatheter body, the sheath having a second opening formed through anouter wall thereof; wherein: the sheath is movable between at least afirst position and a second position such that, in the second position,at least a portion of the second opening of the sheath is approximatelyaligned with the first opening of the catheter body, and, in the firstposition, no portion of the second opening of the sheath is aligned withthe first opening of the catheter body.
 2. The catheter system of claim1, wherein the sheath is rotatable relative to the catheter body.
 3. Thecatheter system of claim 1, wherein the sheath is axially movablerelative to the catheter body.
 4. The catheter system of claim 1,wherein the second opening is approximately the same size as the firstopening.
 5. The catheter system of claim 1, wherein the second openingof the sheath is approximately aligned with the first opening of thecatheter body when the sheath is in the second position.
 6. The cathetersystem of claim 1, wherein the catheter body further comprises a secondlumen formed axially through at least a portion of the catheter bodyconfigured to communicate with an expandable balloon supported at adistal end of the catheter body.
 7. The catheter system of claim 1,wherein the catheter body further comprises a second opening formedthrough at least a portion of the catheter body, the second openingbeing in communication with the first lumen, the catheter system beingselectively configurable such that a guidewire can be passed through atleast the distal end portion of the first lumen and exit the catheterbody at the proximal end of the catheter body or through the first orsecond opening.
 8. The catheter system of claim 1, wherein the firstopening is substantially covered by the sheath when the sheath is in thesecond position to at least inhibit a guidewire from passing through thefirst opening.
 9. The catheter system of claim 1, wherein the catheterbody comprises a lumen configured to receive a mandrel to increase thestiffness of the catheter body adjacent to the first opening.
 10. Thecatheter system of claim 1, further comprising a mandrel that isextendable through at least a portion of the catheter adjacent to thefirst opening to increase the stiffness of the catheter body adjacent tothe first opening.
 11. The catheter system of claim 10, wherein themandrel extends through at least a portion of an inflation lumen of thecatheter body.
 12. The catheter system of claim 10, wherein the mandrelis axially removable from the catheter body.
 13. The catheter system ofclaim 10, wherein the mandrel comprises an opening axially through atleast a portion thereof.
 14. The catheter system of claim 1, furthercomprising a mandrel that is advanceable through at least a portion ofthe first lumen, the mandrel being configured to divert a guidewirepassing through a distal end of the first lumen through the firstopening of the catheter body.
 15. The catheter system of claim 14,wherein the mandrel comprises an angled surface at a distal end thereof.16. The catheter system of claim 1, further comprising indexing featuresto maintain the axial or radial alignment of the sheath relative to thecatheter body.
 17. The catheter system of claim 1, further comprisingdetents, depressions, or protrusions configured to selectively bias thesheath in one of a plurality of axial or radial positions relative tothe catheter body.
 18. A catheter system comprising: a catheter bodycomprising a proximal end, a distal end, and a first lumen axiallyformed through at least a portion of the catheter body, the first lumenbeing configured to receive a guidewire; and a diverter that can bepositioned at any of a plurality of positions along the length of thecatheter body; wherein the diverter is configured such that at least aportion of the diverter passes through the catheter body into the firstlumen such that an opening formed in the diverter communicates with thefirst lumen, whereby a guidewire that is advanced through the firstlumen can be advanced through the opening formed in the diverter. 19.The catheter system claim 18, wherein the first lumen is substantiallysealed along the length thereof.
 20. A method of using a catheter,comprising: advancing a catheter body over a guidewire positioned withina bodily vessel so that the guidewire passes at least partially througha first lumen formed axially through at least a portion of the catheterbody and through a first opening of the catheter body; wherein the firstlumen extends continuously through the catheter body from a distal to aproximal end of the catheter body; closing a portion of the first lumenproximal to the first opening of the catheter body so that the guidewireis prevented from advancing through the first lumen proximal of thefirst opening of the catheter body; moving a sheath positioned about thecatheter body from a first position, wherein the sheath substantiallycovers the first opening, to a second position, wherein at least aportion of the first opening is not covered by the sheath; and divertingthe guidewire so that, when the sheath is in the second position, theguidewire passes through the first opening formed in the catheter bodyas the catheter is advanced over the guidewire.
 21. The method of usinga catheter of claim 20, wherein moving a sheath positioned about thecatheter body from a first position to a second position comprisesmoving the sheath in an axial direction relative to the catheter bodyfrom the first position to the second position.
 22. The method of usinga catheter of claim 20, wherein moving a sheath positioned about thecatheter body from a first position to a second position comprisesrotating the sheath relative to the catheter body from the firstposition to the second position.
 23. The method of using a catheter ofclaim 20, wherein the sheath comprises a second opening alignable withthe first opening formed in the catheter body when the sheath is in thesecond position.
 24. The method of using a catheter of claim 23, furthercomprising rotating the sheath relative to the catheter body from thefirst position to the second position.
 25. The method of using acatheter of claim 23, further comprising diverting the guidewire throughthe second opening formed in the sheath as the catheter is advanced overthe guidewire.
 26. A method of using a catheter, comprising: advancing adistal portion of a catheter body over a guidewire positioned within abodily vessel so that the guidewire passes through a lumen formedaxially in the catheter body; and diverting the guidewire through aside-wall opening formed in the catheter body, the side-wall openingbeing in communication with the lumen; advancing the distal portion ofthe catheter into an introducer sheath positioned in a patient's body toa treatment site while maintaining a proximal portion of the catheterbody at least up the side-wall opening proximal to the introducersheath.